Delving into the Latest Updates on Daratumumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Daratumumab (Genetical Recombination), 达雷木单抗, JNJ-54767414

+ [6]

Target

CD38

Action

inhibitors

Mechanism

CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesEndocrinology and Metabolic Disease+ [7]

Active Indication

Smoldering Multiple MyelomaImmunoglobulin Light-Chain AmyloidosisRefractory Multiple Myeloma+ [19]

Inactive Indication

Adult Lymphoblastic LymphomaB-cell lymphoma refractoryExtranodal NK-T-Cell Lymphoma+ [12]

Originator Organization

Janssen Global Services LLC

Active Organization

Janssen-Cilag International NVJanssen Research & Development LLC

Xian-Janssen Pharmaceutical Ltd.

+ [17]

Inactive Organization-

License Organization

Genmab A/S

Janssen Biotech, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (16 Nov 2015),

Multiple Myeloma

RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan), Conditional marketing approval (China), Orphan Drug (Japan)

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Structure/Sequence

Sequence Code 9075449L

Source: *****

Sequence Code 9946743H

Source: *****

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

Start Date01 Apr 2026

Sponsor / Collaborator

The University of Arkansas

[+1]

NCT07072585

/ Not yet recruitingPhase 2/3IIT

A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

Start Date30 Mar 2026

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT07221032

/ Not yet recruitingPhase 1IIT

Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma

This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.

Start Date01 Mar 2026

Sponsor / Collaborator

Medical College of Wisconsin

100 Clinical Results associated with Daratumumab

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100 Translational Medicine associated with Daratumumab

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100 Patents (Medical) associated with Daratumumab

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2,108

Literatures (Medical) associated with Daratumumab

01 Jan 2026·CLINICA CHIMICA ACTA

Laboratory diagnostic in multiple myeloma: Quantification of daratumumab blood levels using isoelectric focusing

Article

Author: Reiter, Rieke ; Nockher, Wolfgang Andreas ; Mann, Christoph

OBJECTIVES:

Therapeutic monoclonal antibodies (tmAbs) such as daratumumab (DmAb) are among the primary treatment options for multiple myeloma. The availability of immunoassays for measuring tmAb blood levels is limited, although determining antibody concentrations may be of interest in cases of unexpected clinical outcomes. As has previously been demonstrated, isoelectric focusing (IEF) can be used to identify tmAbs and their differentiation from paraproteins. Here, the use of IEF for measuring tmAb concentrations is further expanded.

METHODS:

First, a DmAb standard series ranging from 2.5 to 0.08 mg/L spiked with a polyclonal IgG background of 2.5 mg/L was defined and evaluated. After establishing the standard series, the DmAb concentrations were analyzed in patient blood samples collected one to five weeks post-administration, depending on the time after administration and the corresponding therapy phase.

RESULTS:

DmAb concentrations stabilized three to four weeks after administration. Within a therapy cycle, profound differences in DmAb levels were observed when comparing the induction, consolidation and maintenance phase.

CONCLUSION:

IEF is a suitable tool for evaluating blood concentrations of DmAb and possibly other tmAbs in case of challenging therapy response.

01 Jan 2026·BIOMATERIALS

CD38-targeted antibody-polymer drug conjugates for enhanced treatment of multiple myeloma

Article

Author: Li, Shannuo ; Al Faruque, Hasan ; Yang, Jiyuan ; Li, Jiahui ; Kopeček, Jindřich ; Sborov, Douglas W

Multiple myeloma (MM) remains a formidable disease, especially in relapsed or refractory cases when there are limited treatment options. In this study, we introduce two polymer-antibody drug conjugates (pADCs), ISA-P-EPI (U6244-021) and DARA-P-EPI (U6244-031), which contain semitelechelic N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-epirubicin (EPI) conjugate attached to CD38-targeting antibodies Isatuximab (ISA) and Daratumumab (DARA). These pADCs enhance therapeutic efficacy by combining the specificity of ISA and DARA with the cytotoxic potency of EPI while preserving antibody function. The EPI is linked to the HPMA polymer backbone via a tetrapeptide spacer cleavable by lysosomal enzymes, enabling drug release upon endocytosis within tumor cells. This design achieves a higher drug-to-antibody ratio than conventional ADCs for safer delivery of drug payload. In vitro studies demonstrate efficient binding, internalization, and cytotoxic efficacy of these pADCs in MM cell lines. Mechanistic investigations revealed significant therapeutic effects, including cell cycle arrest, immunogenic cell death, and preserved antibody-dependent cellular cytotoxicity (ADCC). In addition, pADCs were effective in 5 out of 8 primary samples, with their efficacy closely correlating with CD38 surface expression levels. To enhance therapeutic outcomes, we employed panobinostat to upregulate CD38 expression, which further improved pADC efficacy. In a preclinical NRG mouse model inoculated with MM.1S-luc cells, pADC treatment significantly delayed tumor progression and prolonged survival, with all treated mice remaining alive at the 100-day endpoint. These findings underscore the potential of CD38-targeted pADCs as a novel approach to combining chemotherapy with immunotherapy for MM treatment, warranting further investigation into their optimization and clinical application.

31 Dec 2025·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

Author: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

640

News (Medical) associated with Daratumumab

07 Nov 2025

·www.prnewswire.com

FDA Approved DARZALEX Faspro® for Adult Patients with High-Risk Smoldering Multiple Myeloma

DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology SAN DIEGO, Nov. 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). DARZALEX Faspro® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma. "DARZALEX Faspro is the first approved treatment in the U.S. for adult patients with high risk smoldering multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "The approval expands the indications for DARZALEX Faspro with ENHANZE, further solidifying its role as a cornerstone therapy across all stages of multiple myeloma." Smoldering multiple myeloma (SMM) is an asymptomatic malignancy that is genomically the same as active multiple myeloma and where these abnormal cells can be detected in the bone marrow.1,2,3 In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S., and approximately 15 percent of those are classified as smoldering.4,5 An estimated 50 percent of patients diagnosed with HR-SMM are likely to progress to active disease within two years of diagnosis.5 Currently, the standard of care for HR-SMM is active monitoring to track signs of biochemical progression and/or end-organ damage. Recent evidence suggests that people at high-risk of progressing to active multiple myeloma could benefit from earlier therapeutic intervention.5 The FDA approval is based on findings from the AQUILA study (NCT03301220), which evaluated the efficacy and safety of DARZALEX Faspro® compared to active monitoring (or "Watch and Wait") in the largest Phase 3 trial in patients with HR-SMM. For more information on the study and its findings, please view Johnson & Johnson's press release issued on November 6, 2025. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indications referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] 1 American Cancer Society. What is Multiple Myeloma? Accessed June 2025. Available at: 2 Oben, B, Froyen, G, Maclachlan, K.H, et al. Whole-genome sequencing reveals progressive versus stable myeloma precursor conditions as two distinct entities. Nat Commun 2021;12(1861). doi:10.1038/s41467-021-22140-0 3 Maura, F, Bergsagel PL. Targeting the Tumor and the Immune System in Smoldering Multiple Myeloma. N Engl J Med. 2025;392:1858-1860. doi: 10.1056/NEJMe2504273 4 American Cancer Society. Myeloma Cancer Statistics. Accessed June 2025. Available at: 5 M.A. Dimopoulos, et al. Phase 3 Randomized Study of Daratumumab Monotherapy Versus Active Monitoring in Patients With High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA Study. Presented at the December 2024 ASH Annual Meeting & Exposition. Abstract JJD-78127. SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo

Drug ApprovalPhase 3Clinical Result

07 Nov 2025

·www.pharmaceutical-technology.com

J&J’s Darzalex gains first FDA approval in smouldering multiple myeloma

Johnson & Johnson’s star oncology drug, Darzalex Faspro, has gained approval from the FDA in smouldering multiple myeloma, marking an indication first. Image credit: Kyle Grillot / Bloomberg via Getty Images. Johnson & Johnson’s (J&J) blockbuster oncology asset, Darzalex Faspro (daratumumab and hyaluronidase-fihj) has gained US approval in smouldering multiple myeloma (sMM). J&J’s CD38-targeting monoclonal antibody (mAb) is now indicated for use in adult patients with high-risk sMM, meaning patients will have access to a treatment option before progression into active disease. This makes it the first drug to ever get the US Food and Drug Administration (FDA) go-ahead in the smouldering population. Darzalex secured FDA approval based on the results of the Phase III AQUILA trial (NCT03301220), which saw the drug significantly improve progression-free survival (PFS) over the ‘watch and wait’ method, which is currently the standard of care (SoC) protocol for sMM. The subcutaneous drug also reduced the risk of disease progression or death by 51% compared with active monitoring, which Jordan Schecter, J&J Innovative Medicines’ VP of R&D for oncology, noted could “improve outcomes for patients at every stage of their disease”. The most common treatment-related adverse events (TRAEs) associated with Darzalex Faspro as a monotherapy in the AQUILA study were diarrhoea, fatigue, musculoskeletal pain, rash, sleep disorders, and upper respiratory tract infection, as well as sensory neuropathy and injection site reactions. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Treatment versus monitoring: weighing up the benefits Schecter stated that Darzalex Faspro could “shift the treatment paradigm” for multiple myeloma (MM), which has traditionally been approached only when patients progress from smouldering to active disease. GlobalData oncology and haematology analyst Biswajit Podder echoed this sentiment, adding that it will achieve this in a “focused way”. He said: “For truly high-risk patients, it offers a real chance to delay progression and organ damage with a convenient subcutaneous option, using a drug with a well-known safety profile.” However, Podder notes that there are some caveats to consider. This includes the multi-year nature of the therapy, its associated infection risk, and the need for careful selection and monitoring of patients on the drug. According to the analyst, the necessity of patient monitoring means that “shared decision-making between healthcare professionals and patients will be key”. Darzalex’s future market impact Now that Darzalex has been approved in the sMM population, it covers ten indications across the MM treatment landscape , of which four are in the front-line setting. It is also approved for use in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed, light-chain (AL) amyloidosis, making it the first targeted therapy to obtain approval for this indication. Due to its widespread role in multiple myeloma, Darzalex has become a best-seller for J&J, pulling in $3.6bn for the company in Q3 2025 alone . According to a GlobalData report , the drug will also be one of four major drivers for the market’s growth up to 2032. GlobalData is the parent company of Pharmaceutical Technology . Podder noted that Darzalex’s approval in the sMM indication pulls the drug further upstream, which will “increase overall exposure and reinforce J&J’s dominance across the myeloma continuum” – setting a benchmark competitors must beat. However, Podder caveats that the strict high-risk criteria and payer controls may gate Darzalex’s future uptake in sMM. Analysts at GlobalData forecast that sales of Darzalex will peak at $16.8bn in 2029. From this point onwards, they will decline, hitting a value of $15.5bn in 2031. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Phase 3Drug ApprovalClinical Result

07 Nov 2025

·www.biopharmadive.com

Patient dies in Intellia trial; FDA awards 6 more ‘national priority’ vouchers

Today, a brief rundown of news from Intellia Therapeutics and the Food and Drug Administration, as well as updates from Eli Lilly, Gilead Sciences, Johnson & Johnson and Recursion Pharmaceuticals that you may have missed.A study volunteer whod received an experimental gene-editing treatment from Intellia Therapeutics in a Phase 3 trial has died, the company said in its Thursday earnings report. Intellia voluntarily paused dosing in that study as well as another late-stage trial in late October, when that patient was hospitalized due to a spike in liver enzyme and bilirubin levels. The Food and Drug Administration formally put the two studies on hold days later. Intellia is now suspending guidance for the program, nexiguran ziclumeran or nex-z, pending alignment with regulators. The incident clearly complicates the path forward for nex-z, heightens the safety overhang and puts Intellias broader transthyretin amyloidosis program at risk, wrote Leerink Partners analyst Mani Foroohar. Intellia shares, which have already lost about 40% of their worth in recent weeks, tumbled to less than $10 apiece early Friday. Gwendolyn WuThe FDA announced the six latest recipients of its new national priority review vouchers, which are meant to drastically speed up drug evaluations. The list includes two obesity medications Eli Lillys pill orforglipron and an oral version of Novo Nordisks semaglutide as well as the gene editing therapy Casgevy and the tuberculosis antibiotic Sirturo. Two cancer medicines, Jemperli for rectal tumors and Hernexeo for HER2-positive lung cancers, were awarded vouchers too. The FDA revealed the first nine award winners last month, bringing the total number to 15 so far. Though approvals arent guaranteed, reviews for these therapies can take as little as one to two months. Ben FidlerEli Lillys experimental amylin-targeting drug eloralintide helped people with obesity and at least one related complication lose between 10% and 20% of their body weight in a 48-week Phase 2 trial, according to trial data disclosed Thursday and published in The Lancet. The study assessed four different doses of eloralintide along with two step-up dosing strategies and compared weight loss for people using those regimens to those who got a placebo who, by comparison, lost on average 0.4% of their body weight. Lilly will start a Phase 3 trial of eloralintide by the end of 2025 and is considering pairing it with other obesity drugs, like Zepbound, that modulate appetite and metabolism. Jonathan GardnerTrodelvy, a so-called antibody drug conjugate from Gilead Sciences, failed a late-stage study testing it as an early treatment for a common type of advanced breast cancer. The study enrolled around 650 people with HR-positive/HER2-negative metastatic breast cancer, and assessed whether Trodelvy was any better than chemotherapy at slowing the disease when used first following hormone therapy. Gilead said the drug did not meet that measure. The company didnt release any detailed data, but said its trial will keep going to assess Trodelvys effects on overall survival the gold standard in cancer research. In the U.S., Trodelvy is already approved for use in people with HR-positive/HER2-negative breast cancer that continues to advance even after two other systemic therapies. Its also used against a different, triple-negative form of breast cancer. Jacob BellThe FDA has approved Johnson & Johnsons antibody drug Darzalex for people whose early-stage, or smoldering, multiple myeloma is at high risk of progressing into active disease. The approval was based on study results showing Darzalex cut the risk of progression to symptomatic disease or death in half when compared to standard of care, which is to actively monitor patients for disease signs. J&J said the approval makes Darzalex the first treatment for high-risk smoldering multiple myeloma, meaning it could help slow disease progression in thousands of people each year. Jonathan GardnerAI drug discovery specialist Recursion Pharmaceuticals is swapping CEOs, bringing its current chief R&D and commercial officer Najat Khan to the top executive seat starting Jan. 1. In a Wednesday announcement, the company said outgoing CEO and co-founder Chris Gibson will become chairman of the board of directors and stay on as an interim executive advisor. Current chair Rob Hershberg, meanwhile, will transition to vice chairman and lead independent director. Recursion shares have lost most of their value since a big initial public offering in 2021. The company has been streamlining operations and trimming its research pipeline since merging with Exscientia last year. Gwendolyn Wu '

Phase 3Phase 2Drug ApprovalClinical Result

100 Deals associated with Daratumumab

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KEGG	Wiki	ATC	Drug Bank
D10777	Daratumumab	L01XC24	DB09331

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Smoldering Multiple Myeloma	European Union	Janssen-Cilag International NV	24 Jul 2025
Smoldering Multiple Myeloma	Iceland	Janssen-Cilag International NV	24 Jul 2025
Smoldering Multiple Myeloma	Liechtenstein	Janssen-Cilag International NV	24 Jul 2025
Smoldering Multiple Myeloma	Norway	Janssen-Cilag International NV	24 Jul 2025
Immunoglobulin Light-Chain Amyloidosis	European Union	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Iceland	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Liechtenstein	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	Norway	Janssen-Cilag International NV	20 May 2016
Refractory Multiple Myeloma	European Union	Janssen-Cilag International NV	20 May 2016
Refractory Multiple Myeloma	Iceland	Janssen-Cilag International NV	20 May 2016
Refractory Multiple Myeloma	Liechtenstein	Janssen-Cilag International NV	20 May 2016
Refractory Multiple Myeloma	Norway	Janssen-Cilag International NV	20 May 2016
Relapse multiple myeloma	European Union	Janssen-Cilag International NV	20 May 2016
Relapse multiple myeloma	Iceland	Janssen-Cilag International NV	20 May 2016
Relapse multiple myeloma	Liechtenstein	Janssen-Cilag International NV	20 May 2016
Relapse multiple myeloma	Norway	Janssen-Cilag International NV	20 May 2016
Multiple Myeloma	United States	Janssen Biotech, Inc.	16 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Residual Neoplasm	Phase 3	United States	Janssen Research & Development LLC	26 Apr 2019
Residual Neoplasm	Phase 3	Canada	Janssen Research & Development LLC	26 Apr 2019
Amyloidosis	Phase 3	United States	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	United States	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Japan	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	Japan	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Australia	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Australia	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	Belgium	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	Belgium	Janssen Research & Development LLC	10 Oct 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2025	Phase 2/3	Multiple Myeloma First line	3,624	Daratumumab-containing regimens	tltiufhrkg(xsgdvztzff): RR = 0.6 (95.0% CI, 0.42 - 0.85), P-Value = 0.01 View more	Negative	17 Oct 2025
				Standard therapies
NCT03792620 (Pubmed)	Phase 2	Multiple Myeloma CD38	24	Daratumumab, Cyclophosphamide, Thalidomide, Dexamethasone	rzyyraqtsm(dblruzcwae) = cnhuamarvd ugxoxbmwrm (bdbjokphhg, 68.3 - 98.7)	Positive	01 Aug 2025
NCT04230304 (CTgov)	Phase 2	Recurrent Chronic Lymphoid Leukemia \| Chronic lymphocytic leukaemia refractory \| Refractory Small Lymphocytic Lymphoma	8	Ibrutinib+Daratumumab	shelzwlehu = ixedtiwwzi imygszrfgp (zahlhspbvu, yjvjlijsat - qpjoiuqsss) View more	-	01 Jul 2025
NCT03012880 (CTgov)	Phase 2	Multiple Myeloma	80	lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort A)	spbteawpzm = xyeyrojnyj rpghaqqkpq (unphfbwhls, fhadltopkh - bfsrbihgwi) View more	-	04 Jun 2025
				lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort B)	spbteawpzm = ftbbzbkldi rpghaqqkpq (unphfbwhls, daobdzelio - trupsrdgwm) View more
ASCO2025	Not Applicable	Multiple Myeloma	804	Daratumumab	wouwaijkzv(nqbytvywwr) = ffkdrdifcy avagpvlqvj (ioloszgjyz ) View more	Positive	30 May 2025
				Lenalidomide	wouwaijkzv(nqbytvywwr) = iwsluwxeis avagpvlqvj (ioloszgjyz ) View more
NCT04661137 (phase 2b study of selinexor, ASCO2025)	Phase 2	Multiple Myeloma	28	Selinexor 80 mg + Carfilzomib 20 mg/m2 + Dexamethasone	sfxempidvf(sjysyaxdaz) = hniewjbfac dqbgccuvah (zzhhmdsuyo ) View more	Positive	30 May 2025
				Selinexor 60 mg + Pomalidomide 4 mg + Dexamethasone	sfxempidvf(sjysyaxdaz) = luqdkwsgih dqbgccuvah (zzhhmdsuyo )
NCT04268498 (ADVANCE, ASCO2025)	Phase 2	Multiple Myeloma minimal residual disease (MRD) positive	306	DKRd (Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone)	iohmkurgfh(logkyczfrj): adjusted OR = 2.5 (95% CI, 1.5 - 4.2) View more	Positive	30 May 2025
				KRd (Carfilzomib, Lenalidomide, Dexamethasone)
CEPHEUS (EHA2025)	Phase 3	Multiple Myeloma del(17p) \| t(4;14) \| t(14;16) ... View more	395	DARATUMUMAB, BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE (DVRd)	qfgqoxvrcp(kxbntkwomg) = krhcamtcfv mezapynhcj (jnjehapvki ) View more	Positive	22 May 2025
NCT04181827 (CARTITUDE-4, CTgov)	Phase 3	Relapse multiple myeloma \| Multiple Myeloma	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	chcxaebcug(metkhjfsup) = fwttnynjep eiqnwcmeyt (webukwosba, ybahxhatub - pgxkgqxvgt) View more	-	20 May 2025
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	chcxaebcug(metkhjfsup) = ajfwghjmvo eiqnwcmeyt (webukwosba, vjmlrxppju - bbcdscpcbn) View more
NCT04268498 (ADVANCE, EHA2025)	Phase 2	Multiple Myeloma	306	DKRd	wczagvwnvl(gcpkdefmzg) = upudjajtco rvufgvfxmd (zxnflhguns ) View more	Positive	14 May 2025
				KRd	wczagvwnvl(gcpkdefmzg) = xfstkcdnwb rvufgvfxmd (zxnflhguns ) View more

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Daratumumab

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